FDA 510(k)

腹腔镜喷雾器带旋转卢尔接头

K号: K162077 · 2016-08-11

申请人Micromedics, Inc. (D/B/A Nordson Medical)

决定日期2016-08-11

产品代码GCJ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Laparoscopic Spray Applicator with Spinning Luers is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). It received FDA 510(k) clearance on 2016-08-11 under 510(k) number K162077. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Laparoscopic Spray Applicator with Spinning Luers?

Laparoscopic Spray Applicator with Spinning Luers is a medical device that received FDA 510(k) clearance on 2016-08-11. The listed applicant is Micromedics, Inc. (D/B/A Nordson Medical). The 510(k) number is K162077.

When did Laparoscopic Spray Applicator with Spinning Luers receive FDA 510(k) clearance?

Laparoscopic Spray Applicator with Spinning Luers received FDA 510(k) clearance on 2016-08-11, under 510(k) number K162077.

Who is the listed applicant for Laparoscopic Spray Applicator with Spinning Luers?

The FDA 510(k) record lists Micromedics, Inc. (D/B/A Nordson Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laparoscopic Spray Applicator with Spinning Luers?

The FDA product code for Laparoscopic Spray Applicator with Spinning Luers is GCJ.

列明Micromedics, Inc. (D/B/A Nordson Medical)为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K173385移植物输送，DePuy Synthes K172672Endoscopic Applicator, 41 cm

相关器械（代码：GCJ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

官方来源

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